70 of 74

The drug and cosmetic act and rules

9,840 views

 Share

 Like

 Download

 ...

Jobin Kunjumon Vilapurathuu

, Asst. Professor
Follow

Published on Nov 13, 2015

A detailed description on the Pharma Laws prevailing in India

...
 Published in: Law
 1 Comment
 28 Likes
 Statistics
 Notes

Post


동현 조 , --
good!
11 months ago

The drug and cosmetic act and rules

1. 1. The Drug and Cosmetic Act and Rules Jobin Kunjumon Vilapurathu Asst. Professor Grace college of Pharmacy
2. 2. • Compilation of Drug and Cosmetic Acts 1940 and Rules 1945 • Passed with objective of regulating the import, manufacture,
sales and distribution and sale of drugs and cosmetics. • Acts and rules are amended from time to time, the major amendment
being made on 1982. • Schedule M (GMP) and Schedule Y (CR) were introduced in 1988. • Main object of the act is to avoid
substandard of drugs in order to maintain high standard of medical treatment.
3. 3. Definitions • Ayurveda Sidha and Unani Drugs: o Include all medicines indented for internal or external use for or in
diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals & manufactured exclusively in
accordance with the formulae prescribed in authoritative books of Ayurvedic, sidha and Unani tibb systems of medicines. •
Central License approving authority: o Means Drug Controller of India appointed by the Central Government. • Drug: o Includes
a) all medicines used for the internal or external use of human beings or animals and all substances indented to be used for or in
diagnosis, treatment , mitigation or prevention of any disease or disorder in human beings or animals including preparation
applied for repelling mosquitoes b) substances indented to affect the structure or any function of human body or indented to be
used for the destruction of vermin or insects that cause disease in human beings or animals c) all substances indented for use as
components of drug including empty gelatin capsules d) devices indented for internal or external use in the diagnosis, treatment,
mitigation or prevention of disease or disorder in human beings or animals.
4. 4. • Manufacture: o Include any process or part of process for making, altering, ornamenting, finishing, packing labeling,
breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the
compounding or dispensing of any drugs or packing of any cosmetics or drug in ordinary course of retail process. • Patent or
Proprietary Medicine: o In relation to Ayurveda, Sidha or Unani systems of medicine all formulations containing only such
ingredients mentioned in the formulae described in authoritative books of Ayurveda, Sidha or Unani Tibb systems of Medicine
specified in the first schedule but does not include medicine which is administered by parenteral route also formulations included
in authoritative books as mentioned in the first Schedule. o In relation to any other system of medicine, a drug which is a remedy
or prescription presented in form ready for internal or external administration of human beings or animals and which is not
included in edition of the Indian Pharmacopoeia for the time being or any Pharmacopoeia authorized in this behalf by the Central
Government after constitution with the DTAB.
5. 5. • Misbranded drugs: A drug is deemed to be misbranded – o If it is so colored, coated, powdered or polished that damage is
concealed or if it is made to appear of better or great therapeutic value than it really is. o If it is not labeled in prescribed manner;
or o If its label or container or anything accompanying the drugs bears any statement, design or device which makes any false
claim for the drug or which is false or misleading in any particular. • Adulterated Drugs: A drug is deemed to be adulterated – o
If it consists in whole or in part, of any filthy, putrid or decomposed substance; or o If it has been prepared, packed or stored
under insanitary conditions whereby it may have been rendered injurious to health; or o If its container is composed in whole or
in part, of any poisonous or delirious substances which may render the contents injurious to health. o If it bears for purpose of
coloring only a color other than one which is prescribed. o If it contains any harmful or toxic substance which may render it
injurious to health; or o If any substance has been mixed there with so as to reduce its quality or strength.
6. 6. • Spurious Drugs: A drug is deemed to be spurious – o If it is imported or manufactured under a name which belongs to
another drug.; or o If it is an imitation or is a substitute for, another drug or resembles another drug in a manner likely to deceive
or unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drugs; or
o If the label or container bears the name of an individual or company purporting to be the manufacture of the drug, which
company or individual is fictious or does not exist. o If it has been substituted wholly or in part by another drug or substance; or
o If it purports to be the product of a manufacturer of whom it is not truly a product. • Misbranded Cosmetics: A cosmetic is
deemed to be misbranded – o If it contains color which is not prescribe; or o If it is not labeled in prescribed manner; or o If the
label or container of anything accompanying the cosmetic bears any statement which is false or misleading in particular.
7. 7. • Spurious Cosmetics: A cosmetic is deemed to be spurious – o If it is imported under a name which belongs to another
cosmetic; or o If it is an imitation of, or a substitute for, or resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal
its true character and its lack of identity with such other cosmetic; or o If the label of the container bears the name of an
individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious and does not
exist; or o If it purports to be the product of a manufacturer of whom it is not truly a product.
8. 8. • Drug and Cosmetics Rules have been divided into 18 parts each dealing with a particular subject. There are 2 schedules to act
and 26 schedules to Rules. • First Schedule: Name of books under Ayurvedic Sidha and Unani Tibb Systems. • Second Schedule:
Standard to be complied with by imported drugs manufactured for sale, sold, stocked or exhibited for sale or distributed. The
Appendices prescribed are o I – Data required to be submitted with application for permission to market a new drug. o II –
Format for submission of Clinical Trial Reports. o III – Animal toxicity requirements for clinical trials and marketing of new
drugs. o IV – Number of animals for long term toxicity studies. o V – Patient consent for participation in a Phase I Clinical trial.
o VI – Four groups of fixed dose combinations and their data requirements.
9. 9. Important Schedules to rules • A – Performa for application of licenses, issue and renewal of licenses, for sending memoranda
under the act. • B – Rates of fee for test or analysis by the Central Drugs Laboratory or the Government analyst. • C – List of
biologicals and special products whose import, sale, distribution and manufacture are governed by special provisions. • D – List
of drugs exempted from the provisions of import of drugs. • H – List of prescription drugs • J – Diseases or ailments which a
drug may not purport to prevent or cure. • K – Drugs exempted from certain provisions relating to the manufacture of drugs
10. 10. • M – Good Manufacturing Practices (GMP) requirements of factory premises, plants and equipment's. • N – List of
minimum requirements of efficient running of Pharmacy • P – life period of drugs. • S – Standards of Cosmetics. • T –
Requirements of factory premises and hygienic conditions for Ayurvedic and Unani drugs. • U – Particulars to be shown in
manufacturing, raw materials and analytical records of cosmetics. • V – Standards for patent or proprietary medicines. • W – List
of drugs to be marketed under generic names only. • X – List of drugs whose import, manufacture and sale are governed by
special provisions. • Y – Requirements and guidelines on Clinical Trials for import and manufacture of new drugs.
11. 11. Administration of the Acts and Rules • For efficient administration of the acts and rules, the following agencies have been
provided: • Advisory o Drugs Technical Advisory Board (DTAB) o Drugs Consultative Committee • Analytical o Central Drugs
Laboratory o Drugs Control Laboratories in States o Government Analysis • Executive o Licensing Authorities o Controlling
Authorities o Drugs Inspectors o Customs Collectors
12. 12. Drugs Technical Advisory Board • Constituted by Central Government to advise the Central and State Governments on
technical matters arising out of administrations of the Act • It consists of 18 members of whom 8 are ex-officio, 5 nominated and
5 elected members. • Ex-officio members o Director General of Health Sciences ( Chairman) o Drugs Controller of India o
Director, Central Drugs Laboratory Calcutta o Director Central Research Institute, Kasauli o Director Indian Vetenary Research
Institute, Izantnagar o President, Pharmacy Council of India o President, Medical Council of India o Director, Central Drug
Research Institute, Lucknow.
13. 13. • Nominated Members o 1) Two persons nominated by central Government from amongst persons who are in charge of drugs
control in states. o 2) One person from Pharmaceutical Industry nominated by the Central Government. o 3) Two Government
Analysts, nominated by Central Government. • Elected Members o 1) A teacher in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of an Indian university or an affiliated college, elected by the Executive Committee of Pharmacy
Council of India. o 2) A teacher in medicine or therapeutics on the staff of an Indian University or an affiliated College, elected
by the Executive Committee of PCI o 3) One Pharmacologist elected by the Governing body of ICMR o 4) One person elected
by council of Central Medical Education o 5) One person elected by Council of IPA. • The nominated and elected members hold
the office for three years but are eligible for renomination and re-election. • The Central Government appoints a Secretary and
provides the clerical and other staff to the board. • The board may appoint sub-committees and may appoint persons who are not
board members either temporarily or for some period not exceeding 3 years.
14. 14. The Central Drugs Laboratory • Provides for the establishment of a Central Drugs Laboratory under the control of a director
appointed by Central Government. • The Laboratory established in Calcutta has been entrusted with the following functions o 1)
to analyze or test samples of drugs or cosmetics sent to it by the cosmetics collectors or courts. o 2) to carry out such other duties
entrusted to it by the Central Government or with its permission, by State Governments, after consultation with DTAB. • The
Central Research Institute, Kasauli carries out functions in respect of sera, solutions of serum, proteins for injections, vaccines,
toxins, antigens, antitoxins, sterilized surgical ligatures and sutures and Bacteriophages. • Vetenary Research Institute, Izantnagar
and Mukteshwar carries out functions in respect of antisera, vaccines, toxoids & diagnostic antigens, all for Vetenary Use.
15. 15. • Samples of condoms are sent to Central Pharmacopoeial Laboratory, Ghaziabad. • Samples of oral poliomyelitis vaccines
are sent to Pasteur Institute of India. • Central Government has additional laboratories as reference centers on AIDS. • Functions
in respect of all homeopathic medicines are carried out at Homeopathic Pharmacopoeial Laboratory, Ghaziabad. • Samples sent
by courts for analysis or test to CDL should be sent by registered post in a sealed packet, enclosed together with memorandum in
the prescribed form, in an outer cover addressed to the Director. The package as well as outer cover must be marked with a
distinguishing number. A copy of memorandum and specimen impression of the seal should be sent separately to the Director by
registered post.
16. 16. • On receipt of the package, it should be opened by an officer authorized in this behalf by the Director, who should record the
condition of the seal on the packet. Result of the test must be sent to the sender Certificates issued must be signed by the Director
or any other officer authorized by the Central Government in this behalf by notification in Official gazette.
17. 17. The Drugs Consultative Committee (DCC) • DCC is constituted by the Central Government in order to secure uniformity in
the Act throughout India. • It is an advisory committee for the central and State Governments and the DTAB. • It consisted of
two representatives nominated by the Central Government and one nominee of each of the state Governments. The committee
meet when required by the Central Government & is empowered to regulate its own procedure.
18. 18. Government Analysts • State Government by notification in the Official Gazette, appoint persons having sufficient
qualifications to be government Analysts for such areas in state & in respect of such drugs and classes. • Central Government
may also similarly appoint Government Analysts in respect of such drugs or classes of drugs or cosmetics as specified. • No
person having any interest in the import, manufacture or sale of drugs or cosmetics or is directly or indirectly engaged in any
trade or business connected with manufacture of drugs can be appointed as Government analysts.
19. 19. • Qualifications o A graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University and have 5
yrs post graduate experience in testing of drugs in a laboratory under the control of 1)a Government Analyst or 2) head of
approved Institution or testing laboratory. o A Post Graduate in medicine/science/pharmacy/pharmaceutical chemistry of
recognized University with at least 3 years of experience in the testing of drugs in a laboratory under the control of 1)a
Government Analyst or 2) head of approved Institution or testing laboratory. • Duties of Government Analyst o Analyze or test
samples of drugs/cosmetics sent to him by inspectors or other persons under the act and to furnish reports of the results of test or
analysis. o Forward to Government from time to time, reports giving the results of analysis works and research with a view to
their publication at the discretion of Government. • Procedure o On receipt of package of sample from an Inspector the
Government Analyst should compare the seals on the package with the specimen seals and note its condition. On completion of
test, reports in triplicate together with full protocols of the tests or analysis should be sent to the Investigator. o Government
 Analyst has to submit a report in form 1 and unless full protocols are supplied, the report cannot be regarded as conclusive
evidence.
20. 20. Licensing Authorities • Any application for the grand or renewal of license for the import, manufacture, sale, distribution etc
of any drug or cosmetic is to be made to the LA. Drug Controller, India has been notified as Central License Approving
authority. • Qualifications o He should be graduate in Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in
Clinical Pharmacology/Microbiology from a recognized University; & o He has experienced in manufacture or testing of drugs
or enforcement of the provisions of act for a minimum period of 5 years.
21. 21. Controlling Authorities • Drug Inspectors appointed under the act are under the control of a controlling authority •
Qualifications o He should be graduate in Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in Clinical
Pharmacology/Microbiology from a recognized University; & o He has experienced in manufacture or testing of drugs or
enforcement of the provisions of act for a minimum period of 5 years.
22. 22. Drugs Inspectors • Appointed by Central and State Governments. • He should be a person with out any financial interest in
the import, manufacture or sale of drugs or cosmetics. • They are deemed as public servants and are officially subordinate to the
Controlling Authority. • Qualifications o For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical
Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a recognized University; o For inspection
of manufacture of substances in Schedule c, the DI must have 1) at least 18 months experience in manufacture of at least one of
the substance specified in schedule C 2) at least 18 month experience in testing one of the item in schedule C 3) gained
experience of NLT 3 yrs in inspection of firms manufacturing any of the substances of Schedule C during their tenure as services
as DI
23. 23. • Powers of DI o He can Inspect • any premises wherein any drug or cosmetic is being manufactured and the means employed
for standardizing and testing the drug or cosmetic; • any premises wherein any drug or cosmetic is being sold, or stocked or
exhibited or offered for sale, or distributed ; o Take samples of any drug or cosmetic • which is being manufactured or being sold
or is stocked or exhibited or offered for sale, or is being distributed; • from any person who is in the course of conveying,
delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee; o At all reasonable times with necessary
assistance • search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of
which an offence relating to manufacture sale or distribution has been, or is being, committed; or
24. 24. o enter and search any place in which he has reason to believe an offence relating to manufacture, sale or distribution of drugs
or cosmetics has been, or is being committed; or o stop and search any vehicle, vessel, or other conveyance which, he has reason
to believe, is being used for carrying any drug or cosmetic in respect of which an offence has been, or is being, committed, and
order in writing the person in possession of the drug or cosmetic not to dispose of any stock that of for a specified period not
exceeding 20 days or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic,
seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been ,or is being,
committed o examine any record, register, document or any other material object with any person or in any place mentioned
above and seize the same if it is likely to furnish the evidence as an offence o require any person to produce any record, register,
or other document relating require any person to produce any record, register, or other document relating to the manufacture for
sale or for distribution of any drug or cosmetic n respect to which an offence has been committed
25. 25. o exercise such other powers as may be necessary for carrying out the purposes of the Acts or Rules. • Duties of Inspectors o
A) Inspection of premises licensed for sale: • Inspect NLT twice an year all establishments licensed for sale of drugs within the
area assigned to him and to satisfy himself that the conditions of license are being observed. • Procure and send for tests or
analysis, if he has reason to think that the drugs are sold in contravention of provisions of Acts or Rules. • To investigate any
complaints made to him in writing & to institute prosecutions in respect to the braches of the act. • To maintain all records of
inspections made & actions taken by him including taking of samples and seizure of stocks & to submit copies of such records to
the CA • To make enquiries sand inspections as may be necessary to detect sale of drugs in contravention to the Act. • When so
authorized by State Governments to obtain imported packages which he has reason to suspect to contain drugs whose import is
prohibited.
26. 26. o B) Inspection of Manufacture of Drugs • Inspect NLT twice a year all premises licensed for the manufacture of drugs
within the area allotted to him and satisfy himself that the condition of license and provisions of Acts and Rules are observed. •
In establishments licensed to manufacture products specifies in Schedule C and C1 inspect the process of manufacture, means
employed for standardizing and testing of drugs, methods & place of storage, technical qualifications of staff employed & all
details of location, construction & administration of establishment likely to affect the potency or purity of drug. • To send
controlling authority after each inspection a detailed report indicating conditions of license & provisions of Acts & Rules which
are being observed & which are being not observed. • To take samples of drugs manufactured on premises & send them for test
or analysis. • To institute prosecutions in respect of breaches of Act and Rules.
27. 27. • Procedure of Inspectors o An Inspector taking any samples must pay its fair price & may require written acknowledgement
for the same. If price tendered is refused or when Inspector seizes any stock of any drug or cosmetic, he should issue the receipt
for the same in prescribed form. (Form 16) o He should inform the concerned person, the purpose of taking the sample in form
17 & divide the sample to four parts In his presence. Each portion is then sealed & suitably marked. The person from whom the
sample is taken must also be allowed to add his mark of seal on the packet. If sample taken from a manufacturing premises, it
should be divided to three portions only. o If the sample if made into small volume is likely to deteriorate, Inspector can take
three or more containers when necessary after suitably marking it. o One portion of sample is to be restored to the person, second
part send to Government analyst and third one is preserved for production before the court, if required & fourth is sent to
warrantor if any. o Inspector should sent sample to Government Analyst by registered post or by hand in sealed packet enclosed
together with memorandum in Form 18 in an outer cover addressed to Government analyst.
28. 28. o If the confiscated drug is not of standard quality, it should be reported to court accordingly & court may order destruction
of drug under the supervision of Inspector in presence of such authority that the court may prescribe. o If confiscated drug is of
standard quality, Inspector may report court accordingly and court may order sale of drugs by public auction to any party holding
a requisite license. o Any record, register or any other document sized by the Inspector should be returned to the persons from
whom they where seized or who produce the same within a period of 20 days of such seizure or produce. o When an Inspector
seizes any record, register or document, or any other material object, he should as soon as inform the same to the judicial
magistrate & take his orders to the custody thereof. o Every person for time being in charge of any premises where any drug or
cosmetic is manufactured or is kept for sale or distribution, on being required by the Inspector is legally bound to disclose to the
inspector the place where drug or cosmetic is being manufactured or kept. o Willfully obstructing the Inspector or refusing to
provide any record or register is punishable with imprisonment up to three years, or with fine or both.
29. 29. Schedule M • Good Manufacturing Practices (GMP) • Guidelines are meant to assure the quality of drugs. • Draft of GMP
was prepared in 1975 & finalized & implemented in 1988 • Part I deals with Good manufacturing practices relating to factory
premises. • Part II deals with plant & equipment for the manufacture of drugs.
30. 30. Factory Premises • General Requirements o Location of factory & its surroundings should ensure freedom from
contamination due to sewage drain, etc & obnoxious odors or fumes, or large quantity of soot, dust or smoke. o Factory building
should be constructed to ensure production of drugs under hygienic conditions. o Operations such as manufacturing, processing,
packing labeling & testing should be carried out in such a way that mix up & cross contamination are prevented. o Premises
should be constructed and maintained as to prevent entry of insects & rodents, Interior surface should be smooth & free from
cracks & permit easy cleaning disinfection. Adequate lighting, ventilation & humidity must be maintained. Drainage systems
should be underground, the sanitary fitting & electrical fixtures in the manufacture area must be concealed. Water used must be
free of pathogenic micro organisms and of drinkable quality. Waste water should be treated before disposal.
31. 31. o There should be a validated system for the treatment of water so as to produce purified water confirming to IP specification.
Water should be stored in tanks and freedom from microbial growth must be ensured. The tanks should be cleaned periodically
and the records should be maintained. o Provisions should be made for the roper storage of the materials awaiting disposal. The
disposal of sewage and effluents shall be as required under the Environmental Pollution control board while all biomedical waste
must be destroyed as per the rules of Biomedical Waste Management and Handling rules. • Warehousing Area o Adequate areas
shall be designed & provided with proper bins, racks & platforms for the storage and warehousing of all materials & products,
machine & equipment's etc. Warehousing area must be clean, dry & maintained within acceptable temperature limits. Storage
areas should have appropriate house keeping & rodents, pests & vermin control procedures & records should be maintained. o
Active raw materials and excipients must require separate sampling and warehousing area. o Regular checks should be made to
ensure adequate steps taken against spillage, breakage and leakage of containers.
32. 32. • Production Area o Should be designed to allow the production preferably in uni-flow & with logical sequence of operations.
o The equipment's and materials must be placed orderly & the movement of personnel must be restricted to avoid cross
contamination. o Separate dedicated self containing facilities should be made available for the production of sensitive
pharmaceutical products like penicillin or biological preparations with live microorganisms. o Pipe works, electrical fittings,
ventilations, openings & similar service lines must be designed to avoid creation of recesses. o Service lines shall preferably
identified by colors & nature of supply and direction of flow shall be indicated. • Quality control area o Should be independent of
production area & divided to separate sections for physio-chemical, biological, microbiological & radio isotope analysis.
33. 33. o Laboratories shall be designed to avoid mix-ups and cross- contamination. Separate instrument room with adequate area
shall be provided for sensitive & sophiscated instruments employed for analysis. o Suitable storage space shall be provided for
test samples, retained samples, reference standards, reagents & records. • Personnel o Manufacture/testing shall be conducted
under the direct supervision of competent technical staff & head of quality control laboratory shall be independent of
manufacturing unit. o Personnel in quality control and quality control operations shall be suitably qualified & experienced &
appropriate training must be given to them in the duties & responsibilities assigned to them. • Health, Clothing & Sanitation of
workers o All personnel coming to contact with products & raw materials should be free from contagious diseases & should
undergo periodic health check up. Just before entry to manufacturing area, room with facility for personnel cleanliness should be
provided.
34. 34. o Prior to employment, personnel shall undergo medical examination & shall be free from TB, skin and other
communicable/contagious diseases. o Periodical medical examination at least once an year may be necessary. o All persons prior
to & during the employment shall be trained in practices that ensure personnel hygiene. o Persons handling beta lactam
antibiotics shall be tested for penicillin sensitivity before employment and those handling sex hormones, cytotoxic substances &
other potent drugs shall be periodically examined for adverse effects. o Direct contact shall be avoided b/w unprotected hands of
personnel 7 raw materials, intermediate, or finished unpacked products. o All persons should wear clean body coverings. o
Smoking, eating, drinking, chewing or keeping plants or food & personnel medicines shall not be permitted in production,
laboratory storage & other areas. • Ancillary Areas o Rest & refreshment rooms should be separate & should not lead directly to
the manufacturing area. o Facilities for changing, storing of clothes & for washing & toilet purposes should be provided and must
be adequate for the number of users.
35. 35. • Sanitation in Manufacturing premises: o Manufacturing area should not be utilized for any other purposes & should be
maintained clear & in orderly manner free from accumulated waste, dust, debris etc. A routine sanitation program must be
exercised. o Production areas shall be well lit, particularly where visual online controls are carried out. • Raw Materials: All raw
materials must be o Purchased from approved sources under valid purchase vouchers, possibly from producers directly. o
Identified & their containers examined for damage& assigned control number. o Identified & their containers examined for
damage& assigned control number. o There shall be separate areas for materials under test, approved & rejected. o All incoming
materials shall be quarantined immediately after receipt or processing. o Materials must be stored in such a way that first in/first
expiry, first out principle can be applied. o Only raw materials released by QC department & which are within their shelf life
shall be used.
36. 36. • Sterile Products o Separate enclosed areas provided with air locks, dust free, ventilated with air supply through HEPA
filters are recommended. o Routine microbial counts of area are necessary during manufacturing operation. o Design of area
must avoid possibility of mix up between sterile & non sterile products. o Access to manufacturing area must be restricted to
authorized personnel only. • Working Space o Adequate working space 7 adequate room for orderly placement of equipment &
materials should be provided to eliminate mix up between different drugs 7 cross contamination. o Separate space should be
provided in storage area for “under test”, “approved”, and “rejected”, materials.
37. 37. • Medical Services: Manufacturer must provide facilities for o Adequate facilities for first aid. o Medical examination of
workers at time of employment & periodic check up there after once in a year. o Facilities for vaccination or other exigencies. •
Equipment: Equipment used for manufacture must be constructed, designed, installed & maintained to o Achieve operational
efficiency to attain the desired quality. o Prevent physical, chemical or physiochemical change through surface contact. o Prevent
contact of any substances required for operation of equipment's such as lubricants. o Facilitate thorough cleaning whenever
necessary. o Minimize any contamination of any drugs and their containers during manufacture.
38. 38. • Master Formula Records: The Licensee ‘d maintain master formula records relating to all manufacturing procedures for
each product. The master formula record shall give o Patent or proprietary name of product along with generic name. strength &
dosage form o Description or identification of final containers, packaging materials. Labels & closures to be used. o Identity,
quality & quantity of each raw materials to be used. o Description of all equipment's & vessels & the size used in the process. o
Manufacturing & control instructions along with parameters for critical steps such as mixing, drying, blending, sieving,
sterilizing the product. o Theoretical yield to be expected from the formulation o Detailed instructions & precautions to be taken
 in manufacture, storage of drugs & of semi-finished products & the requirements in process quality control tests & analysis to be
carried out during each stage of manufacture.
39. 39. • Batch Manufacturing Records: Licensee ‘d maintain batch manufacturing records for each batch of drugs as per Schedule
U. it ‘d provide complete account of manufacturing history of each batch showing that it has been manufactured, tested &
analyzed in accordance with manufacturing procedures & written instructions as per master formulae. • Manufacturing
Operations & Control: All manufacturing operations must be carried out under the supervision of competent technical staff.
Critical steps in the process related to selection, weighing & measuring of raw materials must be done under the direct
supervision of competent technical staff. • Product containers & closures: ‘d comply with Pharmacopoeial requirements. Suitable
test methods, cleaning & sterilization procedures ‘d be used to assure that components, closures & other component part of drug
packages are suitable & they are not reactive, additive, absorptive, adsorptive or leach to an extent that significantly affects the
quality or purity of the drug.
40. 40. • Labels & other printed materials: Printed labels & packaging materials including leaflets ‘d be handles & accounted to
ensure that they don not become intermixed. Prior to issue, they should be examined & released as satisfactory for use by quality
control personnel. • Distribution of Records: Records for the distribution of each batch of drug should be maintained in order to
facilitate prompt & complete recall of the batch if necessary. • Quality control system: Principal duties of quality control
department are. o Prepared detailed Instruction for carrying out each tests & analysis. o To release or reject i) each batch of raw
material, ii) semi-finished products if necessary, iii) packaging & labeling materials & final containers, iv) each batch of finished
products ready for distribution. o Evaluate adequacy of conditions under which raw materials, semi- finished products & finished
products are stored. o Evaluate quality & stability of finished products. o To establish, & when necessary revise, control
procedures & specifications. o To examine returned products as to whether such products ‘d be released, reprocessed or
destroyed.
41. 41. Schedule M Part II Plant & Equipment • Recommends the requirements of plant & equipment for the manufacture of drugs
under the following sections. o i) Ointments, emulsions, lotions & suspensions, ii) syrups, elixirs & solutions, iii)pills,
compressed tablets & hypodermic needles, iv) Powders, v) Hard gelatin capsules, vi) surgical dressings other than absorbent
cotton, vii) Eye ointments,, eye lotions & other preparations for external use, viii) pessaries & suppositories, ix) inhalers, x)
repacking of drugs, xi) Parenteral preparations.
42. 42. MANUFACTURE OF DRUGS • Manufacture in relation to any drug or cosmetic, includes any process or part of process for
making, altering, ornamenting, finishing, packing, labeling, braking up or otherwise treating any drug or cosmetic with a view to
its sale & distribution but does not include the compounding or dispensing of any drug or packing of any drug in ordinary course
of retail business • Following licenses are provided for manufacture of drugs under D&C Act 1. Drugs other than those specified
in Schedule C, C1 & X 2. Drugs specified in Schedule C, C1 but not specified in Schedule X 3. Drugs specified in Schedule C, &
C1 4. Drugs specific in Schedule X but not in Schedule C & C1 5. Drugs specified in Schedule C, C1 and X 6. Drugs for the
purpose of examination, test or analysis 7. Loan Licenses 8. Repacking Licenses 9. Blood products
43. 43. • Repacking is also a manufacturing for the purpose of the act. • If drugs are manufactured in more than one set of premises, a
separate application is to be made & separate license shall be issued in respect of each such premises. • Licenses for manufacture
or sale or distribution of drugs are granted or renewed by Central License Approving Authority (CLAA) appointed by the central
government. • CLAA can delegate his power of signing licenses to any other person under his control with approval of the
Central Government.
44. 44. Prohibition for the manufacture & sale of Certain Drugs • From the date notified by the State Government, no person shall
himself manufacture for sale or distribution or sell or distribute- o Any drug which is not of standard quality or is misbranded,
adulterated or spurious; o Any cosmetic which not of standard quality or is misbranded, adulterated or spurious; o Any patent or
proprietary medicine whose formulae is not disclosed on label or the container; o Any drug which purports to cure, mitigate or
prevent any disease specified in Schedule J; o Any cosmetic containing any ingredient which may render it unsafe or harmful for
use; o Any drug or cosmetic in contravention of this act or rules thereunder; o Any drug or cosmetic which has been imported or
manufactured in contravention of the provisions of this Act or Rules thereunder or in contravention of the conditions of a license.
45. 45. • Every person not being manufacturer of a drug or cosmetic or his agent for the distribution shall if so required disclose to
the inspector the name address and other particulars of the person from whom he procured the drug or cosmetic. • A drug or
cosmetic shall not be rendered to be misbranded, adulterated or spurious or below standard quality, if- o There has been added
thereto some innocuous substance or ingredient required for its manufacture or preparation as an article of commerce in state fit
for carriage or consumption, & not to increase the bulk, or weight or measure of the drug or cosmetic or to conceal its inferior
quality or other defect. o In process of manufacture, preparation or conveyance some extraneous substance has been unavoidably
become inter-mixed with it, however this does not apply in relation to any sale or distribution of the drug or cosmetic occurring
after the vendor or distributor becomes aware of such inter- mixture. • There are two types of conditions for all manufacturing
licenses o Conditions which are to be satisfied before a license is granted o Conditions which are to be satisfied after the license
is granted.
46. 46. Manufacture of drugs specified in Schedule C, C1 & X • Application for the license of manufacturing drugs specified in
Schedule C, C1 excluding those specified in Schedule X should be made to the LA or CLAA in Form 27 & for manufacture of
drugs specified in Schedule C. C1 & X in for 27B. Respective licenses are issued in Form 28 & 28B. • Application for including
any additional drug in the license should be accompanied by a fee of Rs.50 for each drug subject to a maximum of Rs.500 •
Conditions for the grant of license: Before the grand of license, the following conditions must be complied by the applicant 1.
The manufacture will be conducted under the active direction of a competent technical staff consisting at least one person who is
a full time employee & who is • A graduate in pharmacy/pharmaceutical chemistry of a recognized University with al least 18
months practical experience after graduation in manufacture of drugs to which this license applies. • A graduate in science of a
recognized University who passed in degree with chemistry or microbiology as principal subject & had al least 3 years
experience in the manufacture of drugs to which the license applies.
47. 47. • A graduate in medicine of a recognized University with at least 3 years experience in manufacture of relevant drugs; or • A
graduate in chemical engineering of a recognized University with at least 3 years experience in manufacture of relevant drugs; or
• Holding any foreign qualification comparable in quality, content and training with above qualifications & is permitted to work
as competent staff by Central Government 2. The factory conditions must comply with the conditions prescribed in Schedule M
and M3 3. Applicant should provide adequate space, plant & equipment for any or all manufacturing operations as prescribed in
Schedule M & M3 4.Applicant should provide adequate staff, premises and laboratory equipment for carrying out such tests for
strength, quality & purity of substances as required under the rules. 5. Adequate facilities for the storage of manufactured drugs
should be provided. 6. Data on stability of drugs that may deteriorate, for fixing the date of expiry shall be furnished to LA. 7.
Licensee shall comply with requirements of GMP. 8. For manufacture of patent or proprietary medicines, data should be
 provided to LA that justifies that the medicines are are stable under conditions of recommended storage. contains such
ingredients & in such quantities for which there is therapeutic justification
48. 48. • License in form 28 & 28B remains valid for a period of 5 years on and from the date on which it is issued. • If application
for renewal is made before its expiry, or application made within 6 months of expiry, after payment of additional fee, the license
shall continue to be valid • License shall deemed to have expired if the application for its renewal is not made within 6 months of
its expiry. • Large Volume Parenteral means the sterile solutions indented for parenteral administration with a volume of 100ml
or more in one container of the finished dosage form indented for single usage.
49. 49. • Conditions of the License 1. Licensee should provide & maintain, adequate staff & adequate premises and plant for the
proper manufacture & storage of substances 2. Licensee ‘d maintain records of the manufacture as per particulars given in
schedule U. 3. Licensee ‘d allow Inspectors to enter any premises where manufacture is carried on & to inspect the process of the
manufacture. 4. Licensee ;d allow inspectors to inspect all registers and records maintained under these rules & to take samples
of manufactured product 5. ‘d inspect LA any changes in expert staff & any material changes in premises or plant since date of
last inspection. 6. On request by LA licensee ‘d furnish form every batch, a sample of adequate quantity for any examination 7. If
any batch has been found out by LA not to confirm with the standards, licensee ‘d withdraw the remainder of batch from sale. 8.
‘d maintain a Inspection book to enable inspector to record his impression. 9. ‘d maintain reference samples of each batch of
drugs manufactured by him, in a quantity twice than that sufficient for conducting all tests. 10. ‘d forward to LA of state a
statement of sales effected to manufacturers, wholesalers, retailers, hospitals, nursing homes, dispensaries every three months.
50. 50. Manufacture of Drugs other than those specified in Schedule C & C1 • Application for the grand or renewal of license for the
manufacture of drugs other than those specified in schedule C, c1 & X ‘d be made to LA in Form 24 & for manufacture of
Schedule X drugs in Form 24F. Respective licenses are issued in form 25 & 25F • Application for grand/renewal of such license
shall be made for up to 10 items in each category in Form 24-A accompanied by fee of 6000 & an inspection fee of Rs. 1500 to
LA & license shall be issued in Form 25A. • Additional fee of Rs 300 per item is payable for each additional item • License in
form 25 or 25F remains valid for a period of 5 years on and from the date on which it is issued. • If application for renewal is
made before its expiry, or application made within 6 months of expiry, after payment of additional fee, the license shall continue
to be valid • License shall deemed to have expired if the application for its renewal is not made within 6 months of its expiry.
51. 51. Manufacture of Drugs for Examination, Tests or Analysis • License is necessary for the manufacture of any drug in small
quantity for the purpose of examination, test or analysis. • If a person proposing to manufacture does not hold license i) to
manufacture drugs other than those specified in Schedule C, C1 & X, or ii) to manufacture drugs specified in Schedule C, C1 in
respect to such drugs; he should obtain license in Form 29. • If drug is not recognized as safe for use, license in Form 29 is only
granted after producing no objection certificate from LA appointed by Central Government. • License remains valid for a period
of one year time • Drugs ‘d be kept in containers bearing labels indicating the purpose for which it has been manufactured. • If
the drugs are to be supplied, it should bear label stating name & address of manufacturer, scientific name of substance & purpose
for which it has been manufactured.
52. 52. • Conditions for License 1. Drugs ‘d be used exclusively for the purpose for which they are manufactured 2. Licensee ‘d
allow inspector to inspect the premises & satisfy himself that only examination, test or analysis is being conducted. 3. Licensee
‘d keep record of quantity of drugs manufactured and supplied to any person. 4. Licensee ‘d maintain inspection book to enable
inspector to record his impression and defects noticed. 5. Licensee must comply with any rules made subsequently and of which
the LA has given him NLT one months notice.
53. 53. Manufacture of New Drugs • Defined as a drug the composition of which is such that it is not generally recognized among
experts as safe for use under conditions recommended; or • suggested on the label & includes any drug the composition of which
is such that the drug as a result of investigations for determining its safety for use under such conditions, is so recognized but
which has not otherwise than during course of such investigations, been used to any large extend for any appreciable length of
time under the said conditions.
54. 54. • Provisions applicable for the manufacture of new drugs whether classifiable under schedule C & C1 or otherwise: o No new
drug can be manufactured unless prior approval of the LA has been taken. o Applicant ‘d produce all documentary & other
evidence relating to the standards of quality, purity, strength & such other information as may be required including the results of
therapeutic trials carried out on the new drug. o While applying for a license to manufacture a new drug, or its preparations an
applicant should produce along with his application evidence that the drug has already been approved.
55. 55. Loan Licenses• A loan license means a license which a LA may issue to a applicant who does not have his own arrangements
for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee. • Issued for the
manufacture for sale or distribution of drugs other than those specified in Schedule C, C1 & X. • Application for license is made
in Form 24-A & the license is issued in Form 25-A. • Before grant of license, the LA or CLAA shall get the premises inspected
by one or more inspectors. • Inspector shall check into all the portions of the plant & shall also inquire in professional
qualification for the technical staff employed. • For the manufacturing of additional items, an application must be made to LA. •
Licensee is required to test each batch of raw materials & finished products & the records must be maintained for a period of 5
yrs from the date of manufacture. (2yrs in case of drugs having expiry date, from the date of expiry) • Loan license is deemed to
be cancelled or suspended if license owned by loan licensee, whose manufacturing facilities is been availed by licensee is
cancelled or suspended.
56. 56. Repacking Licenses • Repacking license are granted for breaking up of any drug other than those specified in Schedule C, &
C1, on application to LA in Form 24B & license is issued in Form25B subject to satisfying the following conditions: 1. The
repacking operation must be carried out under hygienic conditions & under supervision of competent staff namely, a) A person
who holds an approved Diploma in Pharmacy or is an Registered Pharmacist. b) A person who has passed intermediate
examination with Chemistry as principal subject. c) A person who has passed matriculation & has at least 4 yrs practical
experience in manufacturing, dispensing or repacking of drugs. 2. Factory conditions must specify conditions prescribed in
Schedule M. 3. Applicant must have in his premises adequate facilities for the testing of drugs. Which is separate from the
repacking unit. 4. License must be kept at licensed premises & produced on request of DI
57. 57. 5. Any change in competent staff must be reported to LA 6. For repacking of any additional items, application must be made
to LA. 7. The label on repacked drugs should mention the name & address of the licensee & his license number preceded by the
word ‘Rpg. Lic. No.” 8. The license remains valid up to 31st December of the year following the year in which it is grated.
58. 58. Import & Registration of Drug & Cosmetic • Drugs/cosmetics may be imported to India under the authority of a license
excepting those whose import is prohibited. • Some drugs/cosmetics can be imported without any permit, providing they are of
standard quality & statement that they comply with the provisions relating to import has been given to the Customs Collector by
manufacturer or importer. • Registration: o Requirement of registration of premises & drugs manufactured & meant for the
import to India was introduced with effect from 1.1.2003
59. 59. • Registration Certificate means a certificate issued by the LA for the registration of premises & drugs manufactured by the
manufacturer meant for import into & use in India. • An application for the issue of a registration certificate should be made to
LA along with the information & undertaking specified in Schedule DI & DII. Registration certificate remains valid for a period
of 3 years. • Requirements of Schedule D I are as follows I. Particulars of manufacturer & manufacturing premises- i) name &
address of manufacturing premises to be registered. Ii) name & address of partners/directors iii) name & address of authorized
agents in India. Iv) brief profile of manufacturer’s business & research activity v) copy of plant master file. vi) copy of plant
registration/approval issued by authority of concerned foreign country.
60. 60. 2. Particulars of manufactured drugs to be registered under registration certificate- i) name of drug to be registered for import
into & use in India. ii) a copy of approval list of above drugs showing permission for manufacturing/marketing in the country of
origin. iii) a copy of GMP certificates as per WHO guidelines. iv) domestic prices of drugs to be imported in the currency of
country of origin, v) names of drugs which are original products of the manufacturer. 3. Undertaking to declare that- i) that
applicant shall comply with the conditions imposed under acts & rules, ii) applicant report from time to time any changes
pertaining registration certificate or any administrative action taken due to ADR, iii) applicant shall allow LA to enter & inspect
manufacturing premises & to examine process r procedures & allow to take samples of drugs concerned for test, analysis or
examination, in respect to any drug manufactured for which application for registration certificate has been made.
61. 61. • The requirements of Schedule D II are as follows 1. General- i) name of drug/formulation/special product, a brief
description, therapeutic class to which it belongs, Drug Masters file & GMP certificate, ii) list of countries where marketing
authorization for said drug is granted/cancelled/withdrawn/pending, iii) list of countries where said drug is patented & iv)
domestic price of drug n currency followed in country of origin. 2. Chemical & Pharmaceutical Information of the drugs- i)
chemical name, dosage form, composition, source, specifications & tests for identification of active ingredients, iii)
documentation on pack size, storage condition, safety documents on containers & closures, iv) manner of labeling & package
insert, v)three samples of drug/product & outer packing with batch certificate to be submitted, vi) batch test reports of five
consecutive production batches to submitted for every site of manufacturing. 3. Biological & Biopharmaceutical information of
drugs- i) biological control tests applied on starting material/intermediate products/finished products, ii) stability of finished
product, iii) sterility & pyrogen test specification & protocol designs, iv) acute & sub acute toxicity test & specification &
protocol, v) date relating to bioavailability studies & bio equivalence, vi) any other relevant information
62. 62. 4. Pharmacological & toxicological information of drugs- i) executive summary of product mentioning specific & general
pharmacologic actions of drug & pharmacokinetic studies, ii) note on acute, sub acute & long term toxicity studies & details on
specific studies on reproductive toxicity, local toxicity & carcinogenic studies. 5. Clinical Documentation- separate permission
for new drug (under rule 122E) by LA is required & such new drugs requires a brief summary on clinical documentation along
with necessary permission for its registration certificate. 6. Labeling & packaging information of drugs- i) labels should as per
specification under the acts & rules, ii) package inserts ‘d be in English & include following therapeutic indications: posology &
method of administration, contraindications, special warnings & special precautions, interactions, whether pregnancy & lactation
contraindicated, undesirable effects, antidote for over poisoning, effects on ability to drive & use machines, iii) package insert ‘d
include information on list of exepients, incompatibilities, shelf life, special precautions for storage, name & specification of the
container & instruction for use/handling. 7. Specific information for special products- to be supplied separately in annexures A,B
& C.
63. 63. Prohibition of Import of certain drugs or cosmetics • No person can import 1. Any drug/cosmetic which is not of standard
quality 2. Any misbranded, spurious or adulterated drug 3. Any misbranded or spurious cosmetic 4. Any drug/cosmetic for
import for which license is prescribed otherwise than under & in accordance with such license. 5. Any patent or proprietary
medicine unless there is displayed in the prescribed manner on the label the true formulae or list of active ingredients in it. 6. Any
drugs which purports to claim or mitigate any such disease or ailment specified in schedule j in the rules 7. Any cosmetic which
contains an ingredient which may render it unsafe for use. 8. Drugs whose manufacture sale & distribution are prohibited in the
country of origin, 9. Drugs not labeled & packed in prescribed manner 10. Biologicals & other special products after the date of
their expiry as mentioned in label or those not complying with the standards of strength, quality, purity as may be specified. 11.
Any new drug expect with express permission of licensing authority. 12. Any drug/cosmetic, the import which is prohibited
under the rules.
64. 64. Import of Drugs under License or Permit • The following classes of drugs can be imported under the license or permit
granted by LA 1. Drugs specified in Schedule C C1 except those specified in Schedule X 2. Drugs specified in Schedule X 3.
Small quantities of drugs imported for the purpose of examination, test or analysis. 4. Drugs for personal use covered by the
prescription of registered medical practitioner. 5. Any new drug An application for import license must be made to the proper
authority in prescribed form & license remains valid up to 31st December of the year following the year it was granted unless it
was suspended earlier. Aggrieved party has the right to appeal in High Court against an order of the drugs controller of India
canceling the import license granted to him.
65. 65. • A separate license is necessary in respect of drugs from each manufacturer • A separate license is necessary in respect to
drug manufactured in each premises when a single manufacturer abroad has more than one factory. • A single application may be
made & single license may be issued in respect of import of more than one drug or class of drugs manufactured by same
manufacturer. • A change in constitution of licensed firm must be informed to the LA
66. 66. Conditions of Import License • An import license is subjected to the following conditions 1. Manufacturer must observe at all
times the undertaking given by him or on his behalf on Form 9. 2. The license must allow any authorized inspector to enter any
premises where the imported substance is stocked to inspect the means, if any, employed for testing the substances 7 to take
samples. 3. The licensee should furnish a sample adequate for examination as required by LA together with full protocol for tests
if any from all batches or from such batches as directed by LA. 4. If directed y LA the licensee ‘d not sell any batch in respect of
which a sample or protocols are furnished as above until certificate is issued to him by LA. 5. In case the licensee is informed by
LA that the drug does not comply with the prescribed standard, he ‘d recall the entire batch from market as practicable. 6. ‘d
maintain records of all sales of imported substances showing particulars of substances & persons to whom it is sold & such
records must be open for inspection 7. ‘d comply with further requirement as may be prescribed by LA & which has been given
NLT 4 months notice
67. 67. • Import of fixed dose combinations o Application for import or manufacture of fixed dose combination of two or more drugs
shall be made to the LA. LA after satisfied that the fixed dose combination to be imported shall be effective & safe for use in
country shall issue permission in form 45 or Form 46. • Import of Schedule C, C1 & X drugs o An import license is required for
the import of any biological or other special product specified in schedules C, C1 excluding X, & drugs specified in Schedule X.
LA must also be satisfied that the premises where imported substance will be stocked by the importer are equipped with proper
storage accommodation for preserving the properties of imported drugs. Licensee ‘d inform LA any change in the constitution of
licensed firm.
68. 68. • Import of drugs for examination, test or analysis: small quantities of drugs can be imported subject to the following
conditions— 1. Drugs can be imported only under a license in Form 11 2. Substances imported ;s be used exclusively for the
purpose of examination, test or analysis in the place specified or in any other place authorized by LA. 3. Licensee must allow any
authorized inspector to enter & inspect the premises & to investigate the manner in which the substances are being used & to take
samples thereof. 4. Licensee must keep record of samples imported under the license together with their quantities, date of
importation &name of manufacturer, & report these particulars to the LA. 5. Licensee must comply with any further requirement
& of which LA has given him NLT one months notice.
69. 69. Import of Drugs for Personal Use: Drugs whose import is otherwise permitted may be imported in small quantities subject to
the following conditions— 1. Drugs must form part of a passengers bonafide baggage & must be indented exclusively for the
personal use of passenger. 2. Drug must be declared to the Customs Collector, if so directed, 3. The quantity of any single drug
so imported must not exceed hundred average doses. LA may in exceptional cases sanction the import of larger quantities. Import
of drugs by Govt. Hospitals/Medical Institutions for the treatment of patients: Small quantities of new drugs otherwise prohibited
for import may be imported for the treatment of patients suffering from life-threatening diseases or diseases causing serious or
permanent disability by a medical officer of Govt. Hospital or Medical Institution. Application for such import must be made in
Form 12AA.
70. 70. • Import of New Drugs: o No new drug can be imported except with the permission of the LA. While applying for such
permission, all documentary & other evidence relating to standards of quality, purity & strength ‘d be supplied to the LA. •
Procedure for Import of New Drugs: o The drugs ‘d be labeled in conformity with the prescribed rules. All consignments of
drugs to be imported ‘d be accompanied by an invoice or other statement showing the make & address of the manufacturer & the
names & quantities of the drugs. Before importing such drugs, declaration signed by the manufacturer on behalf of the importer
that the drugs comply with the provisions of the Acts & Rules ‘d be supplied to the customs collector. o Customs Collector can
take samples of any drugs in the consignment & forward to the director of laboratory appointed for this purpose by the Central
Government. If report of analysis indicate that the drug in a consignment is not of standard quality the Customs Collector may
direct the imported to export back the consignment to the manufacturer within two months or forfeit the same to Central
Government for destruction.
71. 71. Exempted Drugs: the drugs specified in Schedule D are exempted from provisions of import of drugs as follows Class of
drugs Extend of Conditions of exemption • Substances not indented for medicinal use • Substances used both as drugs as well as
food, eg: condensed or powdered milk, Farex, Oats, Lactose & similar Cereal preparations whether fortified with Vitamins or
otherwise excepting those for parenteral use. • Virol, brovil, Chicken essence & all other similar predigested foods • Ginger,
pepper, cumin, cinnamon & similar spices & condiments of official Quality. • Drugs & Cosmetics imported for manufacture &
export by Units situated in special Economic zones as notified by Government of India in time to time. • Can be imported
without any restriction provided imported in bulk & label indicating that substance is not indented for medicinal use • Exempted
from all provisions regulating import. • Can be imported without restriction provided covered by an import license, import
registration && imported through notified port of entry, subject to conditions that these drugs & cosmetics shall not the diverted
for sale in the Country
72. 72. Places through which drugs may be imported in India • In respect to drugs imported by rail across the frontier with Pakistan •
In respect to drugs imported by rail across the frontier with Bangladesh • In respect to drugs imported by road & rail connecting
India & Nepal • In respect to drugs imported by sea into India • In respect to drugs imported by air into India • Ferozpur
cantonment & Amritsar Railway station • Ranaghat, Bongaon & Mohiassan Railway Stations • Raxaul • Chennai, Kolkata,
Mumbai, Cochin & Kandla • Chennai, Kolkata, Mumbai, Delhi, Ahmedabad & Hyderabad
73. 73. Offences Relating to Import of Drugs • Import of adulterated or spurious drugs/cosmetics or cosmetics containing substances
which may render it unsafe or harmful for use o First Conviction: Imprisonment up to three years & fine up to 5000 o Subsequent
Conviction: Imprisonment up to five years or fine up to 10,000 or both. • Import of any drugs or cosmetics other than referred
above, the import of which is prohibited o First Conviction: Imprisonment up to 6 months or fine up to 500 or both o Subsequent
Conviction: Imprisonment up to one year or fine up to 1000 or both • Import of any drug or cosmetic in contravention of any
notification issued under section 10A o Imprisonment up to three years or fine up to 5000 or both.
74. 74. Application of laws relating to Sea & customs • The Customs Collector & other Officers authorized in this behalf by the
Central Government may detain any imported packages which he suspects to contain any drug or cosmetic the import of which is
prohibited under this act, and report such detention to the drugs Controller, India & if necessary forward any package or sample
to Central Drugs Laboratory for analysis.
50 of 70